IRB Guidance for Students

Student Researchers

This guidance is for students who wish to conduct human subjects research, whether the research takes place at an affiliate institution of the NTR IRB or at another non-affiliated site. Click the plus sign to view the answer to each question below.

Current NTR IRB Affiliated Institutions:
UNT Health Sciences Center John Peter Smith Health Network UNT Dallas

North Texas Regional IRB approval is necessary for ANY research being conducted by NTR IRB affiliated faculty, staff, or students involving human subjects (or identifiable data derived from human subjects) in order to comply with federal regulations and institutional policy. IRB approval cannot be obtained retroactively, and must be obtained prior to initiating any research activities with human subjects (including study recruitment).

Can students serve as the Principal Investigator of a project?

No, NTR IRB procedures state that students cannot serve as PI. Only faculty or staff members can serve as PI; however, students can be listed as key personnel on a project. Adjunct faculty also cannot serve as PI.

How do I know whether I need to submit my project for IRB review?

All studies that fit the federal definition for “human subjects research” require IRB approval before any part of the study is initiated, including subject recruitment. Please visit our Guidance Page which further explains the definition of “human subjects research” and explains how to submit a project to the IRB for a determination letter of “not human subjects research.”

NOTE: The IRB is the final authority when determining whether a project should be considered “research with human subjects,” NOT the researcher.  Researchers should consult the IRB for any projects where it is unclear whether the study is human subjects research. Failing to obtain IRB approval prior to initiating a human subjects research study will be considered non-compliance with institutional policies and federal regulations.

Do I need to submit to the NTR IRB if my study will take place at a non-affiliated site?

Yes, even if your research will take place at another site that is not affiliated with the NTR IRB, you must still submit the project to the NTR IRB for review. Since you are a student at an affiliated institution, the NTR IRB is responsible for overseeing your involvement in the research, even if that research takes place at a non-affiliated site.

How do I submit a project for IRB review?

Studies are submitted for review online on the IRBNet website. However, before you can submit your project in IRBNet, you will need to visit the NTR IRB Forms Page on our website to download the appropriate blank forms and templates that are required as part of your IRB submission. The completed forms and templates will be uploaded as part of your IRBNet submission.

Please note that the PI must sign the project in IRBNet before it is submitted for IRB review. Study personnel are not allowed sign the project on behalf of the PI.

To assist you in preparing your IRB submission, we have created a video tutorial that demonstrates how to use IRBNet – see below.

Will my study be reviewed at the exempt / expedited / full board level?

Simply put, it depends on the procedures in your study that will involve the human participants, as well as the level of risk those research procedures pose to the participants.

The federal government has provided lists of allowable categories for which studies can be reviewed at the Exempt or Expedited levels; all other projects (and all projects that are greater than minimal risk) are reviewed at the Full Board level at the monthly convened IRB meeting.  You can find the full board meeting schedule on our website.

How long will it take for my project to receive IRB approval?

It is difficult to provide an estimate regarding the approval time frame for projects for the following reasons:

  • The IRB Team is continuously receiving new submissions for review, including new studies, study modifications, annual reviews, protocol violation reports, and adverse events. The number of submissions in the IRB queue can vary substantially from day to day. If there are many submissions ahead of yours in the queue, it can take more time for the IRB Team to reach your project in line.

  • The IRB Team is also responsible for many other tasks and duties that are not related to study submissions. For example, we are continuously brainstorming new ways to improve internal processes and provide guidance to our investigators. This does, of course, take staff time. However, by investing time to focus on future improvements, we hope that the protocol writing and IRB submission experience for our investigators will be quicker, easier, and more understandable in the long run.

  • The complexity, quality, and completeness of a submission impacts the time needed to review it. Some projects require more IRB feedback or rounds of revisions than others, which adds time to the IRB review process.

With this in mind, the best thing you can do to ensure that your study has IRB approval when you need it is to SUBMIT EARLY. This means submitting your project months in advance of when you would like to start your research project, not weeks.

Please let us know in advance if you have a deadline for your project; however, we cannot guarantee that we can meet deadlines that do not provide adequate time for a complete review.

We have created a 15-minute video to provide you with more information about the history and perspective of the IRB, as well as ways to avoid common errors with IRB submissions - see below:

What if I need my IRB approval to be able to submit my project for Research Appreciation Day?

Again, you will need to SUBMIT YOUR PROJECT EARLY to ensure that you have adequate time to obtain IRB approval. Please visit the NTR IRB Research Appreciation Day website for more information and submission deadlines.  

What kind of training do I have to complete before I submit my study in the IRBNet system?

A certificate of current Human Subjects Protection Training is required to be submitted for all study personnel on all new projects. The NTR IRB offers this training through CITI:

Human Subjects Protection Training remains active until the expiration date listed on the certificate (often 3 years); when the training expires, it must be retaken. This should be completed before the training expires to prevent a lapse. Failing to maintain current required trainings may be considered non-compliance with IRB procedures.

For additional guidance about needed trainings, please visit our Training for Human Subject Researchers web page.

What should I do if I am still feeling lost?

It’s always an excellent idea to consult the Principal Investigator (PI) on your project for guidance, as they will be best equipped to provide advice for your specific area of study. However, don’t forget that the NTR IRB website has lots of excellent resources and guidance to assist you in preparing your IRB submission. Reviewing the guidance and watching our videos will help you to prepare an IRB application that requires fewer revisions.

If you are still feeling lost after consulting with your PI and reviewing the guidance online, you are always welcome to request a consultation with the IRB staff. Please note that we are happy to assist you with IRB-related questions, but your PI should be your contact for discipline-specific questions and feedback.

Is there a checklist or “cheat sheet” that lists all of the steps in the IRB process?

Yes, there is – NTR IRB Quick Reference Guide

This page was last modified on March 14, 2024